QA Specialist (Biotech) – Graz, Austria

12th October 2021
Vandu Worldwide

Our Client is a pioneering global biotech company, featuring a unique Cell & Gene Therapy Biotech Platform. The company is focused on unlocking the power of cell and gene therapies with this platform to provide life changing treatments at the Point of Care (POCare), to large numbers of patients at drastically reduced costs. The Platform consists of a pipeline of POCare Therapeutics, a suite of hand-selected and customized POCare Technologies for closed processing, and a collaborative, global POCare Network of leading companies, research institutes and hospitals. Working with this Platform, the Company leverages cutting edge science to create a more efficient, scalable, and affordable pathway to patients.

 

Responsibilities

  • Documentation: Preparation, review of QMS Documents (e.g., SOPs, validation protocols, reports).
  • Ensure Management of Change Control, Deviations, CAPA and Trainings are initiated, documented, reviewed and approved in a timely and comprehensive manner.
  • Participate in Validation Activity (e.g., facility, process equipment and clean utilities).
  • Participate in Internal Audit Programs within the organization.
  • Participate in Qualification of various vendors impacting product or process quality.
  • Participate in Quality investigations (e.g., OOS, CAPA, Deviations).

 

Requirements

  • Master’s/ Bachelor’s Degree in Biochemistry, Microbiology, Biotechnology or Chemistry
  • Relevant experience in a similar role in Biopharmaceutical Industry